Special Guests

Chris Miller 

Vice President of Biometrics for Late-Stage Respiratory & Inflammation at AstraZeneca R&D in Gaithersburg, MD. 

He has participated actively in and led multi-national statistical and programming teams in the development and commercialization of a range of medicines, particularly in the areas of respiratory disease and inflammation.  His interests include Patient Reported Outcomes and advancing the science of developing medicines through the use of new technologies, such as Digital & Wearables, Data Science and Information Science.  Chris has held several leadership positions at AstraZeneca since joining the company in 1993, including appointments in Biostatistics, R&D Strategy, Regulatory Affairs, and Health Economics & Outcomes Research.  Previously, he served as a Biostatistician with the Neurosciences Venture at Abbott Laboratories (Abbott Park, IL). He is a graduate of Loyola College in Maryland with a BS in Mathematical Sciences and Computer Science.  He received a Master’s Degree in Statistics with a minor in Mathematics from North Carolina State University. 

Paolo Eusebi

Contract Statistician

Statistician with broad experience in all aspects of biostatistics, epidemiology, and health services evaluation. Interested in consulting offers.

Specialties: Data management, data analysis, research projects.
Knowledge of main statistical software packages such as SAS, STATA, and R. 

JMP Software is proud to support the 200^th episode of The Effective Statistician. 

JMP data analysis software empowers some of the world’s largest and most innovative pharmaceutical and biotech companies to explore process and lab data, understand sources of process variation, learn more from root-cause investigations, and optimize processes and experimental design–all without learning to code. 

www.jmp.com/pharma

Guest Speakers

Alberto Cairo
Knight Chair in Visual Journalism
Podcast Episode: COVID-19 and how charts lie

Alberto Cairo is a journalist and designer, and the Knight Chair in Visual Journalism at the School of Communication of the University of Miami (UM). He is also the director of the visualization program at UM’s Center for Computational Science. He has been head of information graphics at media publications in Spain and Brazil. 

The author of several textbooks, Cairo currently consults with companies and institutions like Google and the Congressional Budget Office, and has provided visualization training to the European Union, Eurostat, the Centers for Disease Control and Prevention, the Army National Guard, and many others. He lives in Miami, Florida.

Stephen Pyke
EVP Clinical Data & Digital Services at Parexel
Podcast Episode: Problems for statisticians to take on

Steve is SVP, Development DDA (Digital, Data & Analytics), a newly created role with accountability to deliver enhanced productivity and efficiency across Development by leveraging technology, data and advanced analytics.  Steve trained as a statistician, first joining the pharmaceutical industry in 1996, since when he has held various leadership roles, mainly in Clinical Development.  Steve began his career in academia (NIMR, LSHTM) where he held research and teaching positions.  He has served in a number of honorary professional positions, including: Chair, PSI (2009-11); Vice President, RSS (2013-2016); Chair, CDISC (2018); Advisory Board, Mathematics in Education & Industry (2017-present).  Steve studied Mathematics and Statistics at, respectively, University of York and Imperial College, London.

Frank Konietschke
Non-parametric Professor at Charitee in Berlin
Podcast Episode: Non-parametric analyses – much more than just the Wilcoxon test!

Frank has done extensive research on methodological developments in nonparametric statistics including ranking procedures and resampling methods for various designs and models. His results are published in numerous publications in various journals including two papers in  “the highest-quality journal” Journal of the Royal Statistical Society Series B. Recently, he published a book on nonparametric statistics the Springer Series in Statistics. He lectured and taught nonparametric statistics on almost every continent and has been invited speak at about 80 different universities, companies, and research institutions. Currently, he is a professor of Statistics at the Charite Berlin, where he leads a research group working on the development and application of statistical methods of translation and early clinical trials.

Diana Stuart
Senior Manager, Programming at Veramed
Podcast Episode: Plotting your career and preparing the terrain

Diana has been programming in SAS since 1996, moving from banking to the pharmaceutical industry in 1998. Her experience includes ten years as an independent contractor and involved working for a number of pharmaceutical companies with a significant global presence. She is an experienced line manager who has a passion for the professional development of programmers and statisticians.

Leveraging 20 years of programming expertise across the pharmaceutical sector, Diana is one of the critical success factors behind the Veramed Graduate Training Programme, which she set up and coordinates each year. Alongside this challenging role, Diana supports employee engagement activities, ensures consistency in approach and advises on line management styles to foster and encourage valued contributions across the company as a whole.

Diana has been actively involved with Pharmaceutical Users Software Exchange (PHUSE) since 2009, editing and contributing to the PHUSE quarterly newsletter and more recently contributing to the PHUSE blogs, as well as active participation in the EU conference across the Professional Development, Industry Starters, University Day and Poster streams. In 2018, Diana was honoured to be made a Lifetime Honorary Member of receive a Lifetime achievement for PHUSE for her significant contribution to the organisation over a number of years.

Matt and Emma Jones
Co-Founder and Chief Executive Officer
Co-founder and Executive Vice President, Statistics at Veramed
Podcast Episode: The Story of Veramed – love and statistics

Matthew’s responsibilities include the provision of strategic direction and operational leadership to the company. He also provides oversight and management for the delivery of key projects.

He began his pharmaceutical career in SAS programming with Oxford Pharmaceutical Sciences (now Quanticate), where he honed his technical skills through various positions of ascending seniority. He subsequently worked in a variety of freelance and permanent programming positions across the industry for both CRO and large Pharma, and developed a deep working knowledge of several different outsourcing models.

He holds a BSc in Economics from the University of Nottingham (1999) and an executive MBA from Cranfield University (2006).

Emma is responsible for enabling the Veramed Biostatistics team to achieve the highest levels of quality from consultancy to reporting. Emma continues to provide statistical consultancy to clients to maintain her statistical acumen.

She has a wealth of experience in vendor oversight, statistical consultancy and of clinical statistical analysis gained from a variety of leading global pharmaceutical companies. She has knowledge in both technical and non-technical aspects of study design and statistical analysis across clinical studies from Phase I-III and multiple therapeutic areas, including oncology, respiratory and immunology.

She holds a PhD in Statistics and is an active member of Statisticians in Pharmaceutical Industry (PSI). Emma was the Conference Chair for the 2015 and 2016 annual conference in London and Berlin, respectively.

Daniel Saure
Principal Clinical Data Scientist at Boehringer Ingelheim
Podcast Episode: Everything you need to know about matching adjusted indirect comparisons

He is currently the Principal Clinical Data Scientist at Boehringer Ingelheim for HTA in all therapeutic areas.

Below is his past achievements and positions:

• 2012: M.Sc. Mathematics with minor International Economics, Johannes-Gutenberg-University of Mainz
• 2012-2016: Institute of Medical Biometry and Informatics Heidelberg, Working group “Systematic reviews & meta-analyses”
• 2016: PhD Medical Biometry on sequential meta-analyses
• 2016-2021: Research Scientist at Eli Lilly & Company, global go-to person for Medical Affairs (MA), Health Technology Assessment (HTA), Real World Evidence (RWE) in Dermatology

Karim Malki
Senior Director, Head of Biomakers and Predictive Analytics at UCB
Podcast Episode: Impact of AI on Clinical Development

He is a Senior Director, Head of Biomakers and Predictive Analytics at UCB.

Institute of Psychiatry
De Crespigny Park
London, United Kingdom

Department: MRC Centre for Social Genetic & Developmental Psychiatry
Profile: https://kclpure.kcl.ac.uk/portal/karim.malki.html

Ian Ratcliffe
Statistician at Veramed
Podcast Episode: Working long hours – is it worth it?

Ian has been a statistician since 2012, having a variety of experience in post-marketing studies, a clinical trial unit, and multiple CROs. Ian has been working at Veramed for the last 18 months after spending 4 years at IQVIA. Additionally, Ian has a passion for the development of others managing a team of direct reports and contributing to Veramed’s Graduate Training Programme. Ian will also be hosting a brand new Veramed podcast which is launching before the end of 2021. He was also a member of the PSI CALC committee for two years, being part of the team that organised the PSI Medical Statistics Careers Event and the new MEDMathS event which took place a few weeks ago. Throughout his career, Ian has taken great care in ensuring that his work-life balance is maintained. Ian has a strong belief that one can have a successful career without having to sacrifice work-life balance.

Justine Rochon
Vice President, Global Head of Biostatistics and Data Sciences (BDS) at Boehringer Ingelheim
Podcast Episode: How to create win-win situations?

She is a psychologist and statistician with professional experience in both academia and pharmaceutical industry. From the very beginning of her career, which was almost 20 years ago, she served as lead trial and project statistician in multiple therapeutic areas (oncology, neurology, cardiovascular, metabolism, and obesity). Besides hands-on work in data management, programming and statistics, she provided strategic input to large healthcare interventions and clinical development programs. In addition, she was responsible for all statistical aspects of product maintenance and product optimization as well as market access activities. About 15 years ago, she has started taking management, director and leadership responsibilities. She also discovered her passion for new ways of working and organizational development meanwhile continuing to deliver accurate and valuable data science. Recently, she got certified as Scrum Product Owner and Agile Leader. This finally brought her in today’s position as Vice President, Global Head of Biostatistics and Data Sciences (BDS) at Boehringer Ingelheim. Justine’s group at BI consists of approx. 450 statisticians and data scientists located at five sites (in Germany, USA, China, and Japan). They provide the ideal combination of the business expert knowledge needed in clinical development with skills needed in data science. 

Besides her daily work in a pharmaceutical company, Justine shares her knowledge and professional experience from academia and industry with others. She is a lecturer of ‘Clinical Trials’ in the Master of Biostatistics at the University of Heidelberg as well as a lecturer of ‘Market Access and Health Economics’ in the Pharma MBA at the Goethe Business School and House of Pharma & Healthcare in Frankfurt, Germany. In addition, she has been active in the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI). Currently, she serves as EFSPI Council/Board member and is chair of EFSPI Statistics Leaders.

Kaspar Rufibach and Jan Beyersmann
Expert Statistical Scientist in Roche Biostatistics and Survival and Event History Analysis
Podcast Episode: The analysis of adverse events done right – SAVVY

Kaspar Rufibach is an Expert Statistical Scientist in Roche’s Methods, Collaboration, and Outreach group and located in Basel.

He does methodological research, provides consulting to Roche statisticians and broader project teams, gives biostatistics trainings for statisticians and non-statisticians in- and externally, mentors students, and interacts with external partners in industry, regulatory agencies, and the academic community in various working groups and collaborations.

He has co-founded and co-leads the European special interest group “Estimands in oncology” (sponsored by PSI and EFSPI, which also has the status as an ASA scientific working group, a subsection of the ASA biopharmaceutical section) that currently has 39 members representing 23 companies, 3 continents, and several Health Authorities. The group works on various topics around estimands in oncology.

Kaspar’s research interests are methods to optimize study designs, advanced survival analysis, probability of success, estimands and causal inference, estimation of treatment effects in subgroups, and general nonparametric statistics. Before joining Roche, Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich.

More on the oncology estimand WG: http://www.oncoestimand.org
More on Kaspar: http://www.kasparrufibach.ch

John Beyersmann

Research Interest

• Survival and Event History Analysis
• Statistical Methodology for Clinical and Epidemiological Studies
• More on Dr. Jan: https://www.uni-ulm.de/mawi/statistics/team/professors/prof-dr-jan-beyersmann/

Imi Dean
Senior Data Scientist (RWD) | Epidemiologist | Oncology & Rare Disease
Podcast Episode: RWE demystified

He is an Epidemiologist and data scientist who is incredibly passionate about evidence-based medicine, elegant study design and scientifically robust analysis. He’s experienced in planning, conducting and analysing both real-world and interventional study data utilizing a wide variety of methods.